Wearable LITUS Device for Osteoarthritis of the Knee: a Randomized Double-Blind Placebo-Controlled Trial

Knee Osteoarthritis Clinical Trial

Official title:

ZetrOZ Wearable Ultrasound Clinical Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02083861
• Other study ID #: OA-03
• Secondary ID: 1R43MD008597-01
• Status: Completed
• Phase: N/A
• Start date: March 2014
• Est. completion date: October 2014

Study information

• Verified date: April 2018
• Source: ZetrOZ, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to measure the effectiveness of a wearable therapeutic ultrasound device in patients with stage I and stage II knee osteoarthritis. The ability of the device to reduce pain, increase mobility, increase range of motion and muscle strength of the affected leg, and improve quality of life in patients with knee osteoarthritis will be evaluated.

Description:

This is an eight week study to clinically evaluate the effect of the low intensity long duration ultrasound (LITUS) device on symptoms of patients suffering from knee osteoarthritis. The device, sam® has been FDA-cleared for use. For the first two weeks of the study, baseline data will be collected as patients report pain scores (NRS) three times per day. During the following 6 weeks, patients will self-apply the wearable LITUS device to their affected knee for 4 hours daily. Each day of the study, pain scores (NRS) will be recorded immediately before application of LITUS device as well as 30 minutes, 2-hours and 4-hours after applying the device. A quality of life assessment (WOMAC), muscle strength and range of motion assessment (JTech) will be performed prior to the patient beginning the protocol and at the conclusion of the protocol.

Up to 93 subjects will be recruited from neighboring communities to the study site. The study is designed to reach a target patient population which includes rural citizens and socioeconomic disadvantaged individuals where non-pharmacotherapies do not exist to manage pain. Subjects will be randomly assigned to active (60%) and placebo groups (40%). The sponsor and investigators are blinded as to which type of device each patient is assigned.

The study will be monitored by an external monitor and a data safety monitoring board (DSMB).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 80 Years

Eligibility

Inclusion Criteria:

• Physician-diagnosed mild to moderate knee osteoarthritis (OARSI atlas grades 1-2) based on fixed-flexion x-ray radiological findings for osteophytes and joint space narrowing within the past 12 months

• Fulfill the American College of Rheumatology clinical and radiological diagnostic criteria for knee OA

• 35-80 years of age

• Report a frequent pain score between 3-7 (NRS range: 0-10) during the week preceding enrollment

• Report that knee pain negatively affects quality of life

• Willing not to use any cream, gel, or topical solution during the administration of treatment other than the approved ultrasound gel provided to the subject at the initiation of the study

• Deemed appropriate by their physician or by the study site physician to participate

Exclusion Criteria:

• Cannot successfully demonstrate the ability to put on and take off the device

• Display any condition which, in the judgment of the investigator, would make participation in the study unacceptable, including, but not limited to, the subject's ability to understand and follow instructions.

• Have severe OA or have little to no cartilage in the knee

• Have knee replacement, other surgical intervention, or hyaluronidase injection in the affected knee in the past 6 months

• Are non-ambulatory

• Participated in a clinical trial for an investigational drug and/or agent within 30 days prior to screening

• Modify their medications during the course of the study (medications and doses must remain constant throughout the study)

• Currently taking steroids

• Have contraindication to radiograph

• Have a secondary cause of arthritis (metabolic or inflammatory)

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Device:
• Sam Ultrasonic Diathermy Device
Patients apply the Sam Ultrasonic Diathermy Device daily for 4 hours of continuous therapeutic ultrasound at 3 megahertz (MHz) frequency and 0.132 Watts/cm2.

Locations

Country	Name	City	State
United States	Medical Pain Consultants	Dryden	New York

Sponsors (3)

Lead Sponsor	Collaborator
ZetrOZ, Inc.	National Institute on Minority Health and Health Disparities (NIMHD), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain on the Numeric Rating Scale (NRS) Change From Baseline to Study Conclusion	The numeric rating scale (NRS) was used to assess change in pain from baseline to study conclusion. NRS range from 0-10 with 0 being no pain and 10 the worst pain possible.	Baseline, Week 6
Secondary	Quality of Life (WOMAC) Change From Baseline	WOMAC questionnaire will be utilized (Western Ontario and McMaster Universities Arthritis Index). WOMAC was divided into 3 categories: pain, stiffness, function and total score. The pain category consists of five scores from 0-10, 0 is no pain 10 is worst pain possible for a range of 0 - 50 points. The stiffness category consists of two scores from 0-10, 0 is no stiffness 10 is worst stiffness possible for a range of 0 - 20 points. The function score consists of 17 scores from 0-10, 0 is normal function and 10 is severely limited function, for a range of 0 - 170 points. Categories were multiplied by 10 for analysis. Total score is the sum of pain, stiffness, and function scores (range of 0 - 2400).	Baseline, Week 6
Secondary	Range of Motion Change From Baseline in Treated Knee	JTech equipment was used to evaluate range of motion range of motion using an inclinometer (www.jtechmedical.com) in flexion and extension of the treated knee. 0 degrees is fully extended and 150 degrees is normal flexion. Positive flexion change indicates improvement in flexion. Negative extension indicates improvement in extension.	Baseline, Week 6
Secondary	Muscle Strength Change From Baseline in Treated Knee	Muscle strength in flexion, extension, and rotation were measured using JTECH muscle testing equipment.	Baseline to 6 Weeks